Myth or Not? Real-world adherence results for a self-administered B-cell therapy: Can it help guide at-home treatment discussions?

[Barry Hendin]

Welcome to “Myth or Not?”

We’ll be discussing some of the common misconceptions regarding KESIMPTA

So, let’s start with our first statement

It’s difficult to self-administer a B-cell therapy at home

[Desiree Chizmadia]

I don’t hear it as frequently anymore, but I still come across some peers who think that all B-cell therapies are infusions or some prefer to keep treatments in house as they have an infusion center because they don’t think patients can self-administer at home

[Brian Wong]

I would agree with that

This class of medications is frequently prescribed in my practice and self-administration may offer patients a sense of control and independence

At-home administration is something that I personally appreciate as an option for my patients

With any treatment, I think about the logistics

What factors can I consider to help with my patients’ compliance?

[Bary Hendin]

So far, a great discussion

But before we go further, let’s quickly go over the basics of KESIMPTA

[Narrator]

KESIMPTA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults

KESIMPTA is contraindicated in patients with active hepatitis B virus (HBV) infection, or history of hypersensitivity to ofatumumab, or life-threatening injection-related reaction to KESIMPTA. Hypersensitivity reactions have included anaphylaxis and angioedema

Warnings and precautions include Infections, Injection-Related Reactions and Hypersensitivity Reactions, Reduction in Immunoglobulins, Liver Injury, and Fetal Risk

Most common adverse events (greater than 10%) are upper respiratory tract infection, injection-related reactions, headache, and local injection-site reactions

[Bary Hendin]

Before we talk about that

It’s important that we cover the pivotal data to provide context to our discussion

ASCLEPIOS I and II were 2 identical, randomized, active-controlled, double-blind Phase 3 studies in patients with relapsing MS

Patients were randomized to KESIMPTA or oral teriflunomide for up to 30 months

The primary end point, annualized relapse rate, showed a reduction of up to 58%

Adverse reactions with an incidence greater than 10% in patients taking KESIMPTA, were upper respiratory tract infections, injection-related reactions, headache, and local injection-site reactions

As you can see in the chart pictured, the adverse events were comparable to teriflunomide

And now that we’ve covered that, Brian, I think you were going to talk and walk us through the considerations for your patients

[Brian Wong]

So again, I like to ask myself, “What's the typical day-to-day look like for a patient and how does the treatment fit with their schedule?”, “What factors can I consider to help my patient's compliance?”

Along with the efficacy and safety data, these questions help me focus on what will be practical for a patient

Now, KESIMPTA is a 20 mg subcutaneous once-monthly treatment, after 3 weekly starter doses

When I think about the patient experience for an at-home, self-administered treatment it is notable that KESIMPTA is the only B-cell therapy that does not require premedication or post-dose observation

That’s because there was only limited benefit to premedication with corticosteroids, antihistamines, or acetaminophen observed in the RMS clinical studies

Of course, we know that the first administration of KESIMPTA should be administered under the guidance of an appropriately trained health care professional

This is a key part of the prescribing information that stands out to me

The patient can start treatment without premedication

This goes back to our first myth

It really is about doing everything we can to fit the treatment into the patient’s lifestyle

[Desiree Chizmadia]

Agree

For my patients, I demonstrate the ease of use by focusing on early education with the KESIMPTA Sensoready Demo Pen, which could help them gain the confidence to use KESIMPTA on their own

Then I go over the features such as the green progress indicator that stops moving when the administration is complete

The pen also clicks twice

1 click when the administration starts and another when it’s almost finished

Total administration time where the needle is under the skin averages to about 3 to 4 seconds when ready to administer

KESIMPTA is the first and only B-cell therapy for RMS that can be self-administered at home or on the go

In my experience, the self-administration helps my patients feel like they have a sense of control

As I reflect upon examples from my practice, being able to self-administer in about 3-4 seconds when ready means that they don’t have to travel to an infusion center for treatments

[Bary Hendin]

And what you said is so relevant, Desiree, because our staff most often are nurses like yourself play a pivotal role in educating our patients on the administration

[Brian Wong]

I echo that, Barry

It’s all about the team you have behind you and your patients

It really does matter if team members are comfortable educating patients on the treatments we prescribe

[Bary Hendin]

And speaking of that, there are data, too, that speaks to how our nurses and patients feel about the Sensoready Demo Pen

Desiree, would you care to walk us through those results?

[Desiree Chizmadia]

Sure

We could look at the results of a multicenter survey

This is based on responses from 50 nurses who treat MS and 80 patients with MS in the US, Germany, France, and Italy

Participants were asked to compare the attributes of the KESIMPTA Sensoready autoinjector pen with those of other DMT autoinjectors, some of which are not available in the US

A total of 17 attributes were assessed, with “easy to perform self-injections with the pen,” “ease of preparation and set-up,” and “ease of training patient in use” among those most preferred

83% of patients and 86% of nurses preferred the Sensoready Pen

[Bary Hendin]

It’s an easy-to-perform self-administration, and “easy to use” is something I hear from patients quite often—and that’s great to hear

But what about adherence?

What are your thoughts on the following

Real-world adherence and persistence data can provide added perspective when discussing treatment options?

[Brian Wong]

When discussing treatment options, I really try to consider patient preferences, my own insights, core data, as well as the latest adherence and persistence data

But before we get into the real-world results, let’s begin with some persistence data measured from (1) the percentage of patients who completed the study on KESIMPTA in the pooled ASCLEPIOS I and II core studies, and (2) the percentage of patients remaining on KESIMPTA from entry into ALITHIOS up to the study cutoff date

For some quick background, ALITHIOS is an open-label, umbrella extension, Phase 3b, single-arm study evaluating long-term, up to 7 years, safety, tolerability, and effectiveness of KESIMPTA in subjects with RMS

Persistence with KESIMPTA in patients with RMS was assessed for up to 4 years

Nearly 90% of patients remained on KESIMPTA in the ALITHIOS study period

If we look at it more closely, we see that in the ASCLEPIOS I and II core study, 82.9% of patients remained persistent with treatment

In the ALITHIOS open-label extension study, 88.5% of patients remained persistent with treatment

And as a reminder, no conclusions of clinical outcomes can be drawn

I have patients who need to be away from home frequently due to their occupations

These patients have flexibility to administer their KESIMPTA at home or on the go

The Sensoready pen should be refrigerated and protected from light

KESIMPTA can be stored at room temperature for up to 7 days and returned to the fridge to be used within the next 7 days

My patients have really appreciated these attributes of the Sensoready pen

[Bary Hendin]

Brian, I’m glad you brought up the real-world patient of your own, because that’s a great segue for Desiree to talk about real-world studies

[Desiree Chizmadia]

So, I appreciate real-world studies because they add a certain perspective that feels more relatable to many of my patients

I’ll just mention here 2 persistence studies assessing KESIMPTA along other therapies, including injectables in one study and orals in the other

Both studies were conducted from August 2020 to November 2021, utilizing the IQVIA PharMetrics® Plus database

Patients were indexed on first observed therapy and followed until discontinuation, switch, or 12 months post index for persistent patients

Propensity score matching was used to balance the baseline demographics, clinical, and RMS characteristics, as well as use of prior DMT between cohorts

Persistence was defined as the number of days from the index date until discontinuation or switching to a new DMT

Discontinuation was defined as a greater than 60-day gap in therapy for Study 1 with KESIMPTA and platform injectables or a greater than 90-day gap in therapy for Study 2 with KESIMPTA and orals

In Study 1, 75% of patients on KESIMPTA and 43% of patients on platform injectables remained on treatment at 1 year

In Study 2, 82% of patients taking KESIMPTA and 68% of patients on orals remained on therapy at 1 year

I can only speak from my experience, but I’m not too surprised by those outcomes

There are some limitation to these studies

For example, analysis using claims data are dependent on the accuracy and specificity of information provided

Caution should be exercised in making any direct comparisons due to differences between DMTs

Findings may not be generalizable to other payor populations due to the study sample consisting primarily of commercially insured patients in the US

If treatment occurred outside the purview of the claims data source, early discontinuation may be overestimated

It’s important to note that no conclusion of the clinical outcomes can be drawn from this data

[Bary Hendin]

Now, I’ve noticed that we haven’t talked about the most recent study on adherence and persistence of KESIMPTA and ocrelizumab

[Brian Wong]

You read my mind, Barry

And like the studies that Desiree just discussed, this is another real-world study to provide perspective outside of a clinical trial setting

In a retrospective cohort study, persistence and adherence were assessed at 24 months for KESIMPTA and ocrelizumab

For some background on this study, it took place between August 2019 and May 2023

The sample included adults with an MS diagnosis in the 12 months prior to or 6 months following the index date

And continuous enrollment in a commercial insurance plan for at least 12 months before and 24 months after the index date

Patients treated with KESIMPTA were matched 1 to 1 to patients treated with ocrelizumab using the greedy nearest neighbor propensity score

Now, for the measurements

Adherence spans the whole post-index period, while persistence is potentially interrupted by discontinuation

So, let’s take a look at the definitions and see why

Adherence was defined as the proportion of days covered greater than or equal to 80%

Persistence was defined by the time in months from the index date until treatment discontinuation

Since treatment discontinuation is variable based on when the patient discontinued within the post-index period, discontinuation was defined as a gap of 60 days in index therapy or switch to another DMT

Let’s now look at the results in the matched KESIMPTA and ocrelizumab cohorts

Starting with persistence, we see that the proportion of patients who were persistent at 24 months post index was 72% and 70%, respectively

Then, for adherence, we see that the proportion of patients who were adherent at 24 months post index was 76% and 78%, respectively

It is also important that we acknowledge the limitations

There are differences in disease-modifying therapy dosing schedules and pharmacodynamics, so caution is advised when making any direct comparisons

Early discontinuation may be overestimated if treatment occurred outside the purview of the claims data source

KESIMPTA received approval in August 2020, resulting in a relatively limited number of patients with sufficient real-world follow-up data to assess persistent and adherence

Also, claims data have inherent limitations, like there may be coding errors and missing data, no reason for discontinuation provided, or problems with ICD-10 codes not identifying patients by MS subtypes

Alright that was a mouthful, and not everyone, including myself, is a statistician

So, let’s break that down to what that means clinically

Overall, I’m reassured to see that these results align with my own experiences

Historically, I’ve been quite comfortable with infusions, like ocrelizumab, for compliance purposes, but as I’ve gained more experience with KESIMPTA, I’ve found that the ease of use really gave my patients confidence in administering KESIMPTA themselves

[Desiree Chizmadia]

Seeing adherence and persistence outcomes for a self-administered and infused therapy is great, because while we know patients have health care provider supervision in clinics, we have put our trust in the patient and the process for home treatment

So, it’s reassuring to have data like this that can add to our joint decision-making discussions

I think that’s why we have to remember that there’s no-one-size-fits-all approach

We should consider what our patients are willing to take, no matter what life throws at them

[Bary Hendin]

Well, I’m really glad that we’ve had adherence and persistence data for KESIMPTA

More information helps everyone understand the entire scope of KESIMPTA, and it empowers patients and clinicians to make a well-informed treatment decision

So, once my patient and I have reached a joint decision on treatment, I want to help them get started on their treatment as soon as possible

And if the decision is KESIMPTA, appropriate patients can start in days rather than weeks with samples

[Desiree Chizmadia]

That has been especially useful in my practice for patients who are anxious to get started and don’t want to wait to get set up for additional appointments

[Brian Wong]

Luckily in my experience, KESIMPTA has been covered for most of my patients

So, I haven’t had many issues, but I like that the support is there if you need it

But of course, it should be noted that coverage is specific to the region and patient

As long as the correct workup has been completed then I can start with samples as soon as the patient is ready

My patients are eager to get started and appreciate this

[Bary Hendin]

And I know that more than 80% of treatment-naïve patients with commercial insurance have first-line coverage for KESIMPTA, with 9 out of 10 patients covered overall

And 97% of commercial patients reported no out-of-pocket costs when using the $0 copay card

[Brian Wong]

To me everything we’ve talked about with KESIMPTA including the easy-to-use pen, quick access to treatment, and the availability of adherence and persistence data, can be incorporated in our shared decision-making discussions

That’s the feedback that I get from my patients and why I consider KESIMPTA as an option for the appropriate patient after shared decision-making discussions

[Bary Hendin]

OK, so in deciding what’s myth or not, we looked at 2 statements

It is difficult to self-administer a B-cell therapy at home

Desiree, would you consider this one myth or not?

[Desiree Chizmadia]

In my opinion, this one is a myth

[Bary Hendin]

I agree with you there

Now onto our second statement

Real-world adherence and persistence data can provide added perspective when discussing treatment options

Brian, what do you think about this one

[Brian Wong]

You know what, I think we should hold on to that one to remind our peers of the adherence and persistence data available

[Bary Hendin]

Alright, I agree, I’ll put this one here for safekeeping

Alright, I wanted you to know that I really appreciate both of you being here with me today

It’s a great pleasure

And I’m sure the viewers are grateful for all of the information that you shared and that we shared in this edition of “Myth or Not?”

And to any listeners who might want to see what else your are saying about KESIMPTA, check out the links to the Digital Education Lab

[Narrator]

Important Safety Information

Contraindications

KESIMPTA is contraindicated in patients with active hepatitis B virus infection, or a history of hypersensitivity to ofatumumab, or life-threatening injection-related reaction to KESIMPTA. Hypersensitivity reactions have included anaphylaxis and angioedema

Infections

Serious, including life-threatening or fatal, infections have been observed during and following completion of treatment with anti-CD20 B-cell depleting therapies. Delay KESIMPTA administration in patients with an active infection until the infection is resolved. Vaccination with live-attenuated or live vaccines is not recommended during treatment with KESIMPTA and after discontinuation, until B-cell repletion

Injection-Related Reactions and Hypersensitivity Reactions

Management for injection-related reactions depends on the type and severity of the reaction

Reduction in Immunoglobulins

Monitor the level of immunoglobulins at the beginning, during, and after discontinuation of treatment with KESIMPTA until B-cell repletion. Consider discontinuing KESIMPTA if a patient develops a serious opportunistic infection or recurrent infections if immunoglobulin levels indicate immune compromise

Liver Injury

Clinically significant liver injury has occurred. Obtain serum aminotransferases, alkaline phosphatase, and bilirubin levels before initiating KESIMPTA, and during treatment as clinically indicated. Discontinue KESIMPTA in patients with evidence of liver injury in the absence of an alternative etiology

Fetal Risk

May cause fetal harm based on animal data. Advise females of reproductive potential of the potential risk to a fetus and to use an effective method of contraception during treatment and for at least 6 months after the last dose

Please see additional Important Safety Information and full Prescribing Information, including Medication Guide, by watching this entire video and by referring to the adjacent panel of this video